BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 3062494 · Received April 17, 2013

    Report

    Report Number
    1030489-2013-01073
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUALLY CONFIRMED APPROXIMATELY ~1.5MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF; THE BROKEN OFF PORTION IS MISSING AND NOT RETURNED FOR ANALYSIS. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, WITH THE TIP JUST BELOW THE FRACTURE SURFACES PLASTICALLY DEFORMED. DIMENSIONAL INSPECTION OF THE RELEVANT DIMENSION CONFIRMED CONFORMANCE TO PRINT SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L3-S1. IT WAS REPORTED THAT THE SURGEON PLACED A SPINOUS CLAMP AT THE L3-4 LEVEL AND LOCKED THE PLATE IN COMPRESSION WITH A SET SCREW. AFTER A VISUAL INSPECTION, THE SURGEON ASKED FOR THE REMOVAL HEAD TO LOOSEN THE SET SCREW. IT WAS REPORTED WHEN THE SURGEON TURNED THE DRIVER COUNTER CLOCKWISE TO LOOSEN THE SCREW. THE TIP OF THE DRIVER SHEARED OFF FLUSH IN THE SET SCREW. THE TIP OF THE DRIVER COULD NOT ME REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164243 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA RS12K008

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR